With reference to the regulation of Medical Devices in India under the Medical Devices Rules, 2017, consider the following statements:
1. The manufacturing licenses for Class A (low risk) and Class B (low-moderate risk) medical devices are issued by the State Licensing Authorities (SLAs).
2. The master risk classification list of all medical devices is maintained and dynamically updated by the Central Licensing Authority (CLA).
3. Valid international certifications such as USFDA or CE markings legally exempt a medical device from requiring a CDSCO or SLA license in India.
Which of the statements given above is/are correct?

Question

Accepted Answer

A) 1 and 2 only — Statements 1 and 2 are correct. Under the Medical Devices Rules, 2017, SLAs issue manufacturing licenses for Class A and B devices, while the CLA maintains the official risk classification list. Statement 3 is incorrect because a valid CDSCO/SLA license is mandatory for the import, manufacturing, or sale of medical devices in India; foreign certifications cannot replace statutory Indian approvals.

CDSCO Strict Risk Classification Directive for Medical Devices

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